Biaxin - Consumer Medicine Information
|Condition:||Bacterial Endocarditis Prevention (Bacterial Endocarditis Prophylaxis), Bronchitis, Dental Abscess, Helicobacter Pylori Infection, Legionella Pneumonia, Mycoplasma Pneumonia, Mycobacterium avium-intracellulare, Treatment, Mycobacterium avium-intracellulare, Prophylaxis, Nongonococcal Urethritis, Otitis Media, Pertussis, Pertussis Prophylaxis, Pharyngitis, Pneumonia, Sinusitis, Skin and Structure Infection, Skin or Soft Tissue Infection, Strep Throat (Streptococcal Pharyngitis), Toxoplasmosis, Tonsillitis/Pharyngitis, Upper Respiratory Tract Infection|
|Form:||Tablets, Powder, Syrup|
|Ingredients:||clarithromycin, cellulosic polymers, croscarmellose sodium, D&C Yellow No. 10, magnesium stearate, povidone, pregelatinized starch (250 mg only), propylene glycol, silicon dioxide, sorbic acid, sorbitan monooleate, stearic acid, talc, titanium dioxide, vanillin|
clarithromycin tablets USP, film-coated
About this Medication
What the medication is used for
BIAXIN BID is used to treat certain infections caused by bacteria, such as pneumonia, bronchitis, infections of the sinuses, skin, and throat.
When used with other medications, it can treat infection caused by a bacterium called Helicobacter pylori (H. pylori) and reduce the risk of duodenal ulcer recurrence. A duodenal ulcer is a sore on the lining of the duodenum, which is the beginning of the small intestine.
It can also be prescribed to prevent and combat MAC disease in patients with HIV. MAC is a short word for Mycobacterium avium complex, the germs that cause MAC disease.
What it does
BIAXIN BID is an antibiotic that kills bacteria in your body.
When it should not be used
Do not take BIAXIN BID if you:
- have ever had an allergic reaction (rash, difficulty breathing) to this product, or if you are sensitive to clarithromycin, erythromycin, other antibacterial agents of the same family, or to any ingredient in this product. See (What the important non-medicinal ingredients are).
- are taking astemizole*, cisapride*, colchicine, pimozide, terfenadine*, ergotamine, dihydroergotamine, lovastatin, oral midazolam, ranolazine*, simvastatin, or ticagrelor.
Astemizole*, cisapride*, pimozide, terfenadine*, ergotamine, dihydroergotamine and colchicine can interact with BIAXIN BID, possibly leading to an irregular heartbeat pattern; deaths have occurred.
- have ever developed liver problems after using BIAXIN BID.
- suffer from severe liver failure in combination with kidney impairment.
- have a history of heart disturbance or irregular heartbeat (arrhythmias, QT prolongation, torsades de pointes).
- have hypokalaemia (low potassium levels in the blood).
*not marketed in Canada.
What the medicinal ingredient is
What the non-medicinal ingredients are
Cellulosic polymers, croscarmellose sodium, D&C Yellow No. 10, magnesium stearate, povidone, pregelatinized starch (250 mg only), propylene glycol, silicon dioxide, sorbic acid, sorbitan monooleate, stearic acid, talc, titanium dioxide and vanillin.
What dosage form it comes in
- regular tablets (BIAXIN BID, 250 mg and 500 mg),
- extended-release tablets (BIAXIN XL, 500 mg),
- liquid form (BIAXIN, 125 mg/5mL and 250 mg/5mL).
Warnings and Precautions
Serious Warnings and Precautions
|BIAXIN BID should not be used in pregnancy unless advised by your doctor due to potential hazards to the fetus. Do not take BIAXIN BID without first talking to your doctor if you are breast-feeding a baby.|
Before taking BIAXIN BID, tell your doctor if you have liver or kidney disease. You may not be able to take clarithromycin, or you may require a lower dose and special monitoring during therapy. Talk to your doctor if BIAXIN BID gives you prolonged and severe diarrhea.
The development of antibiotic resistance has been seen in patients with HIV receiving clarithromycin. To avoid failure of the treatment with a potential for developing antimicrobial resistance and a risk of failure with subsequent therapy, you/your child should follow closely the prescribed regimen.
BEFORE you use BIAXIN BID talk to your doctor or pharmacist:
- about all health problems you have now or have had in the past;
- about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. See INTERACTIONS WITH THIS MEDICATION;
- if you have or develop severe diarrhea as this may be a sign of a more serious condition;
- if you have kidney problems;
- if you have liver problems;
- if you are taking digoxin, atorvastatin, pravastatin, midazolam;
- if you are allergic to other medicines, foods, dyes, or preservatives;
- if you are pregnant, trying to get pregnant or are breast-feeding because clarithromycin has been detected in human breast milk.
WHILE taking BIAXIN BID, contact your doctor if:
- you develop symptoms of myasthenia gravis or the symptoms of your existing myasthenia gravis worsen. These symptoms could include muscle weakness that gets worse with activity and gets better with rest, drooping eyelid, blurred or double vision, difficulty chewing and swallowing, or trouble breathing.
- you develop symptoms of hepatitis (liver inflammation) such as abdominal pain, nausea, vomiting, yellowing of skin and eyes, dark urine etc. Stop taking the drug immediately.
Interactions with this Medication
Drugs that may interact with BIAXIN BID include
Alfentanil, alprazolam, amlodipine, astemizole*/terfenadine*, atazanavir, atorvastatin, bromocriptine, carbamazepine, cilostazol, cisapride*/pimozide, colchicine, cyclosporine, digoxin, diltiazem, disopyramide/quinidine, efavirenz, ergotamine/ dihydroergotamine, etravirine, fluconazole, hexobarbital, insulin, itraconazole, lansoprazole/omeprazole, lovastatin/pravastatin/simvastatin, methylprednisolone, midazolam/triazolam, nateglinide, nevirapine, phenobarbital, phenytoin, pioglitazone, ranolazine*, repaglinide, rifabutin/rifampin, rifapentine*, ritonavir/indinavir, rosiglitazone, rosuvastatin, saquinavir, sildenafil, St. John’s Wort (Hypericum perforatum), tacrolimus, tadalafil, ticagrelor, theophylline, tolterodine, valproic acid, vardenafil, verapamil, vinblastine, warfarin/acenocoumarol, zidovudine and drugs metabolized by cytochrome P450 system.
*not marketed in Canada.
Proper Use of this Medication
BIAXIN BID may be taken with or without meals.
Respiratory Tract or Skin Infections
The usual dosage of BIAXIN BID is 250 mg to 500 mg every 12 hours for 7 to 14 days.
Infections with H. pylori
Triple Therapy: BIAXIN BID + Omeprazole + Amoxillin
The recommended dose is the following for 10 days:
|BIAXIN BID:||500 mg every 12 hours|
|Omeprazole:||20 mg once daily|
|Amoxicillin:||1 g every 12 hours|
The recommended dose of BIAXIN BID for prevention and treatment of MAC disease is 500 mg every 12 hours.
Treatment of disseminated MAC infection (MAC infection spread through your whole body) in patients with HIV should continue for life if improvement of symptoms is observed.
|In case of overdose, contact your healthcare professional, hospital emergency department or regional poison control centre, even if there are no symptoms. Symptoms of BIAXIN BID overdose are abdominal pain, vomiting, nausea and diarrhea.|
If you miss a dose, take it as soon as you remember unless it is almost time for the next dose. In that case, skip the missed dose and take the next one as directed. Do not take double or extra doses.
Side Effects and what to do about them
Like all medicines, BIAXIN BID can cause side effects. The majority of side effects observed in clinical trials with BIAXIN BID were of a mild and transient nature.
The following adverse reactions were reported during the clinical studies with clarithromycin, the medicinal ingredient (occurring between 1% and 10% in clinical trials) or during post-marketing surveillance: abdominal pain, abnormal taste, diarrhea, ear disorder, flatulence, indigestion, headache, nausea, rash, vomiting. Talk to your doctor or pharmacist if any of these side effects persist or become bothersome.
Serious side effects from BIAXIN BID are not common.
If dizziness, confusion or disorientation occur while taking BIAXIN BID, do not drive or operate machinery.
Serious Side Effects, how often they Happen and what to do about them
|Symptom / Effect||Talk with your|
drug and call
your doctor or
*Allergic reactions, with symptoms such as itching, skin eruptions, rash, sore throat, fever, swelling, skin rash, itchiness, difficulty breathing, lightheadedness/dizziness.
This is not a complete list of side effects. For any unexpected effects while taking BIAXIN BID, contact your doctor or pharmacist.
How to Store it
Keep BIAXIN BID and all other medicines out of reach and sight of children.
Store between 15 and 25ºC in a tightly closed container. Protect from light. Do not use beyond the expiration date.
Reporting Suspected Side Effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report on line at
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789
- Mail to: Canada Vigilance Program
Postal Locator 0701D
Ottawa, ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
The most recent version of this document plus the full Product Monograph, prepared for health professionals, can be found at:
or by contacting the sponsor, BGP Pharma ULC, Saint-Laurent, Qc
H4S 1Z1 at: